MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1320-01-S

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem Air Embolism (1697)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for lot number acf62846 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: carto 3 system, model #: m-4800-01, serial #: (b)(4).Smartablate pump, model #: m-4900-08, serial #: (b)(4).Smart touch bidirectional sf catheter, model #: d-1348-05-s, lot #: 17559130l.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a smartablate pump tubing and suffered an air embolism with st segment elevation requiring cardiac catheterization.During the procedure, an air embolism occurred as a result of flushing the smartablate tubing with the stopcock open to the patient.Transient st elevation was observed on the 12 lead ecg reflecting compromise to the right coronary artery (inferior leads).Cardiac catheterization was performed.The patient was reported to be in stable condition at the time the complaint was reported.The case was successfully completed.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

The udi number was not provided in the initial 3500a report.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (b)(6) 2017.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a smartablate pump tubing and suffered an air embolism with st segment elevation requiring cardiac catheterization.During the procedure, an air embolism occurred as a result of flushing the smartablate tubing with the stopcock open to the patient.Transient st elevation was observed on the 12 lead ecg reflecting compromise to the right coronary artery (inferior leads).Cardiac catheterization was performed.The patient was reported to be in stable condition at the time the complaint was reported.The case was successfully completed.There is no information about the hospitalization.Upon receipt, the product was visually inspected and it was found in normal conditions.Flow test performed and product passed all specification.No error or bubble found in tubing.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Complaint was unable to be duplicated.

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6237522
• MDR Text Key: 64364497
• Report Number: 2029046-2017-00013
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1320-01-S
• Device Catalogue Number: SAT001
• Device Lot Number: OEM_D-1320-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening